Quality Control Lead

The Quality Lead is responsible for overseeing inspection activities to ensure compliance with regulatory requirements, internal quality standards, and customer specifications. The Quality Lead demonstrates a strong knowledge of the ISO 13485 and 21 CFR 820 requirements. The Quality Lead interacts professionally with company management, internal departments, and customers on Quality related tasks. This position also manages and maintains day-to-day scheduling and workflow of the Quality Inspectors.

They also support the management team by conducting training, performing troubleshooting, managing the daily shipment schedule, and generally supporting the QC department and Quality functions to ensure compliance with the company’s QMS requirements and established processes.

• Partner with departmental peers in manufacturing, engineering, logistics, purchasing, maintenance, and QC to monitor and ensure compliance with the quality assurance program established by the company.
• Coordinate and manage daily schedules and work assignments of Quality Inspector personnel.
• Lead the QC department in daily activities, such as visual and dimensional inspection, quality testing, Device History Record (DHR) review, and others as assigned.
• Review and approve inspection records, nonconformance reports, and related documentation.
• Cooperate with and act professionally with coworkers and managers.
• Meet Flexan standards for quality, cleanliness, and productivity.
• Follow all procedures for cleanroom operation, cleanroom attire, and contamination control.
• Follow all Flexan procedures for traceability, line clearance, process control, safety, and housekeeping.
• Accurately input data into ERP system daily (including clock in time, work orders worked on, operation worked on, indirect work performed, quantities of parts produced and quantities of parts that are deviated).
• Participate in 5S activities and follow 5S procedures.
• Conduct on-boarding and on-the-job training for new employees as needed.
• Participate in interviewing candidates for inspection roles, assessing technical skills, and cultural fit.
• Work closely with the Quality Manager to provide objective feedback and recommendations for development plans, training needs, and performance evaluations for inspection personnel.
• Manage and maintain Flexan’s quarantine locations and ensure proper disposition of parts/materials.
• Assist with root cause investigations driven through nonconformance reports (NCs) and CAPAs.
• Assist with internal and external audits, providing inspection-related documentation and evidence of compliance.
• Assist in risk management activities including preventive actions, pFMEA and Control Plans.
• Assist in the development of Dimensional, Quality Control, and other process sheets or work instructions.
• Work with Engineering to develop vision system measurement teaching files for dimensional inspection.
• Lead the execution of Gage R&Rs and other validation activities within the QC department.
• Perform dimensional and visual inspections.
• Identify opportunities to improve inspection processes, methods, and reduce defects.

• Excellent interpersonal and communication skills, both written and verbal, and presents well at all levels of the organization.
• Works well independently and in a team environment, can lead people that are not direct reports, strong goal setting, follow up, organization and prioritization skills, and excellent attention to detail.
• Strong computer skills and familiar with Microsoft Windows applications.
• Medical Device Manufacturing environment experience preferred.
• Demonstrable ability to analyze a wide variety of information and data to assist management decisions regarding potential risks that may impact product or compliance status.
• Strong attention to detail and ability to multitask.
• Good work ethic (comes to work and returns from lunch and breaks on time, works hard to reach work standards, tries to minimize waste)
• Team player that gets along well with others (respectful of supervisors and co-workers, helps others by offering assistance and ideas when appropriate)
• Able to recognize and address both good and sub-standard performance (praise excellent performance and cooperation, recognize and immediately discuss any safety issues, identify and report interpersonal and attitude problems, recognize and either immediately stop or report any incidences of misuse of tools and equipment)
• Is proactive in identifying potential problems or…